Morrison Vicki A, Johnson Gary R, Schmader Kenneth E, Levin Myron J, Zhang Jane H, Looney David J, Betts Robert, Gelb Larry, Guatelli John C, Harbecke Ruth, Pachucki Connie, Keay Susan, Menzies Barbara, Griffin Marie R, Kauffman Carol A, Marques Adriana, Toney John, Boardman Kathy, Su Shu-Chih, Li Xiaoming, Chan Ivan S F, Parrino Janie, Annunziato Paula, Oxman Michael N
Veterans Affairs Medical Center and University of Minnesota, Minneapolis.
Cooperative Studies Program Coordinating Center, Veterans Affairs Connecticut Healthcare System, West Haven.
Clin Infect Dis. 2015 Mar 15;60(6):900-9. doi: 10.1093/cid/ciu918. Epub 2014 Nov 20.
The Shingles Prevention Study (SPS) demonstrated zoster vaccine efficacy through 4 years postvaccination. A Short-Term Persistence Substudy (STPS) demonstrated persistence of vaccine efficacy for at least 5 years. A Long-Term Persistence Substudy (LTPS) was undertaken to further assess vaccine efficacy in SPS vaccine recipients followed for up to 11 years postvaccination. Study outcomes were assessed for the entire LTPS period and for each year from 7 to 11 years postvaccination.
Surveillance, case determination, and follow-up were comparable to those in SPS and STPS. Because SPS placebo recipients were offered zoster vaccine before the LTPS began, there were no unvaccinated controls. Instead, SPS and STPS placebo results were used to model reference placebo groups.
The LTPS enrolled 6867 SPS vaccine recipients. Compared to SPS, estimated vaccine efficacy in LTPS decreased from 61.1% to 37.3% for the herpes zoster (HZ) burden of illness (BOI), from 66.5% to 35.4% for incidence of postherpetic neuralgia, and from 51.3% to 21.1% for incidence of HZ, and declined for all 3 outcome measures from 7 through 11 years postvaccination. Vaccine efficacy for the HZ BOI was significantly greater than zero through year 10 postvaccination, whereas vaccine efficacy for incidence of HZ was significantly greater than zero only through year 8.
Estimates of vaccine efficacy decreased over time in the LTPS population compared with modeled control estimates. Statistically significant vaccine efficacy for HZ BOI persisted into year 10 postvaccination, whereas statistically significant vaccine efficacy for incidence of HZ persisted only through year 8.
带状疱疹预防研究（SPS）证明了接种疫苗后4年的带状疱疹疫苗效力。一项短期持续性子研究（STPS）证明了疫苗效力持续至少5年。开展了一项长期持续性子研究（LTPS），以进一步评估SPS疫苗接种者在接种疫苗后长达11年的随访中的疫苗效力。对LTPS的整个时间段以及接种疫苗后第7至11年的每一年的研究结果进行了评估。
监测、病例判定和随访与SPS和STPS中的情况相当。由于在LTPS开始前向SPS安慰剂接受者提供了带状疱疹疫苗，因此没有未接种疫苗的对照。相反，使用SPS和STPS安慰剂结果来模拟参考安慰剂组。
LTPS招募了6867名SPS疫苗接种者。与SPS相比，LTPS中带状疱疹（HZ）疾病负担（BOI）的估计疫苗效力从61.1%降至37.3%，带状疱疹后神经痛发病率的估计疫苗效力从66.5%降至35.4%，HZ发病率的估计疫苗效力从51.3%降至21.1%，并且在接种疫苗后第7至11年，所有这3项结果指标的疫苗效力均下降。接种疫苗后第10年，HZ BOI的疫苗效力显著大于零，而HZ发病率的疫苗效力仅在第8年显著大于零。
与模拟对照估计值相比，LTPS人群中疫苗效力的估计值随时间下降。接种疫苗后第10年，HZ BOI的疫苗效力在统计学上仍显著，而HZ发病率的疫苗效力仅在第8年在统计学上仍显著。
